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Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

NCT00643916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2014-02-14

Study results available
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Summary

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Conditions

Interventions

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

0.5 mL, Intramuscular (at age 9 and 12 months)

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

0.5 mL, Intramuscular (at age 9 and 15 months)

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

0.5 mL, Intramuscular (at age 12 and 15 months)

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

0.5 mL, Intramuscular (at age 15 months)

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

0.5 mL, Intramuscular (at age 18 months)

BIOLOGICAL

A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

0.5 mL, Subcutaneous (at 3 years to \<6 years of age)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-03-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643916 on ClinicalTrials.gov